Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.

Influenza A Subtype H5N1 Infection Clinical Trial

Official title:

A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755703
• Other study ID #: H-0701-2
• Secondary ID: #1-UCI-AI-06205-
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2008
• Last updated: December 31, 2015
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.

The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.

Description:

Objectives:

The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 49 Years

Eligibility

Inclusion Criteria:

• Healthy males and females in good general health, 19-49 years of age

• Subjects must provide written consent

• Willing to participate through study completion

• Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis

• Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.

• Meet screening criteria for hematology, chemistry and urinalysis

Exclusion Criteria:

• Pregnant (or possibly pregnant) and lactating women

• Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment

• Any intranasal steroid medication administered in the 10 days prior to study enrollment

• History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities

• Any previous nasal cautery or significant surgery for nasal septal defects

• Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use

• Asthma that is greater than mild in severity

• Diagnosed active Hepatitis B or C

• HIV positive at screening

• Known or suspected malignancy, leukemia, or lymphoma

• Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids

• Receipt of an influenza vaccine within the past 6 months

• Receipt of any vaccine in the past 30 days

• Receipt of any investigational drug in the past 30 days

• Known Diabetes mellitus

• History of anaphylaxis or angioedema

• Hypertension that is not well controlled

• Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenoviridae Infections
• Influenza A Subtype H5N1 Infection
• Influenza, Human

Intervention

Biological:
• Pandemic Influenza Vaccine
Undetermined
• Placebo

Locations

Country	Name	City	State
United States	Alabama Vaccine Research Center (UAB)	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.		56 day observations with 2 year follow-up	Yes
Secondary	Determination of immunogenicity and correlates of protection based on HI titers in vaccinates		28 days and 56 days post vaccination	No